Dr.

Abhishek Pandey

NABL accreditation: Principles and procedures

INTRODUCTION accreditation. The laboratory should carry out the

Accreditation is the formal recognition, authorization following important tasks towards getting ready for
and registration of a laboratory that has demonstrated accreditation:
its capability, competence and credibility to carry out 1. Contact NABL Secretariat with a request for
the tasks it is claiming to be able to do. It provides procuring relevant NABL documents (NABL
feedback to laboratories as to whether they are Contact address and the list of NABL documents
performing their work in accordance with international given in Annexure-3 and 1, respectively).
criteria for technical competence.
2. Get fully acquainted with all relevant documents
The concept of laboratory accreditation was developed to and understand the assessment Procedure and
provide third-party certification that a laboratory is methodology of making an application.
competent to perform the specific test or type of tests. 3. Train a person on Quality Management System
Laboratory accreditation is a means to improve customer and Internal Audit (4-day residential training
confidence in the test reports issued by the laboratory so courses conducted by NABL. Contact NABL
that the clinicians and through them the patients shall Secretariat for details).
accept the reports with confidence.
4. Prepare QUALITY MANUAL as per ISO 15189
The National Accreditation Board for Testing and standards.
Calibration Laboratories (NABL) is an autonomous 5. Prepare Standard Operating Procedure for each
body under the aegis of the Dept. of Science & investigation carried out in the laboratory.
Technology, Govt. of India, and is registered under
6. Ensure effective environmental conditions
the Societies Act. NABL, which was initially
established with the objective to provide accreditation (temperature, humidity, storage placement, etc.).
to testing & calibration laboratories, later on extended 7. Ensure calibration of instruments / equipment.
its services to the clinical laboratories in our country. Only NABL ACCREDITED CALIBRATION
LABORATORIES are authorized to provide
Govt. of India has authorized NABL as the sole
accreditation body for testing and calibration calibration. NABL website gives the names of
laboratories. The objective of NABL is to provide third NABL accredited calibration laboratories in the
party assessment of quality and technical various fields of Accreditation.
competence. Four years ago NABL established links 8. Impart training on the key elements of
with international bodies - Asia Pacific Laboratory documentation, such as document format,
Accreditation Cooperation and International authorization of document, issue and withdrawal
Laboratory Accreditation Cooperation. This has procedures, document review and change, etc.
imparted international recognition to NABL accredited Each document should have ID No., name of
laboratories. The international standard currently controlling authority, period of retention, etc.
followed by NABL is ISO 15189, specific for medical 9. Ascertain the status of the existing quality system
laboratories. and technical competence with regard to NABL
Principle for Accreditation standards and address the question “Is the
system documented and effective OR does it
It is very important for a laboratory to make a definite need modification?”.
plan for obtaining accreditation and nominate a 10. Remember Quality Manual is a policy document,
responsible person as QUALITY MANAGER (who which has to be supplemented by a set of other
should be familiar with the laboratory’s existing quality next level documents. Therefore ensure that
system) to co-ordinate all activities related to seeking these documents are well prepared.
11. Ensure proper implementation of all aspects that
have been documented in the Quality Manual
and other documents.
12. Incorporate Internal Quality Control (IQC) Accreditation Process
practice while patients’ samples are analysed.
An applicant laboratory is expected to submit to NABL
13. Document IQC data as well as uncertainty of 5 copies of the application and 5 copies of Quality
measurements. Maintain Levy Jennings charts. Manual.
14. Participate in External Quality Assessment
The Quality Manual will be forwarded by NABL to
Schemes (EQAS).
a Lead Assessor to judge the adequacy of the
If this is not available for certain analytes,
Quality Manual as to whether it is in compliance
participate in inter-laboratory comparison through
with ISO 15189 standards.
exchange of samples with NABL accredited
Thereafter the Lead Assessor will conduct a Pre-
laboratories.
Assessment of the laboratory for one day. Based
15. Document corrective actions on IQC / EQA
on the Pre-Assessment report the laboratory may
outliers. have to take certain corrective actions, so as to
16. Conduct Internal Audit and Management Review. be fully prepared for the final assessment.
17. Apply to NABL along with appropriate fee. It is essential for the applicant as well as
accredited laboratories to satisfactorily participate

ANNEXURE-1

st,
NABL PUBLICATIONS (Essential for clinical laboratories) (as on July 1 2005)

No. Name of document Document Price

Number Rs.

1. General information brochure NABL - 100 Free

2. Specific Guidelines for Accreditation of
Clinical Laboratories NABL - 112 Free
3. Terms and conditions for Maintaining Accreditation NABL - 131 Free
4. NABL Guidelines to Accredited Laboratories
for use of NABL Logo NABL - 133 Free
5. Guidelines for Estimation and Expression of
Uncertainty of Measurement NABL - 141 250/-
6. Policy on Calibration and Traceability of
Measurements NABL - 142 Free
7. Application Form for Testing Laboratories NABL - 151 Free
8. Guide for Preparing a Quality Manual NABL - 160 250/-
9. Guide for Internal Audit and Management
Review for laboratories NABL - 161 200
10. Policies and Procedures for inter-laboratory
comparisons and / or Proficiency Testing NABL - 163 Free
11. Master list of NABL documents NABL - 200 Free
12. Pre-assessment Guidelines and Forms NABL - 209 Free
13. Interpretation of the Accreditation Criteria and
Guidelines for Assessment NABL - 211 100/-
14. Guideline document on Validation of
Test Methods NABL - 212 100/-
15. Policy and Procedures for assessment,
Surveillance & Re-assessment of laboratories NABL - 214 Free
16. Policies & Procedures for dealing with
Adverse Decisions NABL - 216 Free
 ANNEXURE-2

Financial Terms & Conditions

Lab classification Application Annual

Fee accreditation Fee

Large > 400 Patients/day Rs.50,000/-consolidated Rs.50,000/-

Medium 101-300 Patients/day Rs.20,000/-consolidated Rs.20,000/-
Small upto 100 Patients/day Rs.10,000/-consolidated Rs.10,000/-
Lab to bear assessors’ travel & boarding expenditure.

in Proficiency testing/ Interlaboratory ANNEXURE-3

comparisons/External quality assessment
programme as Asia Pacific Laboratory NABL CONTACT ADDRESSES
Accreditation Cooperation (APLAC) Mutual
NABL Secretariat: B-4 / B-5 / B-6
Recognition Arrangement calls for mandatory
Qutab Hotel Apartments,
participation in such programmes.
New Mehrauli Road,
Finally when the laboratory is ready, the Lead New Delhi - 110016
Assessor and a team of technical assessors will Tel : 011-26529718 /
conduct the final assessment. The number of 19/20
technical assessors will depend on the number of Fax : 011 - 26529716
disciplines applied for. The accreditation process Website : nabl-india.org
involves a thorough assessment of all the
elements of the laboratory that contribute to the
production of accurate and reliable test data. ISO 15189 STANDARDS
These elements include staffing, training,
MANGEMENT REQUIREMENTS
supervision, quality control, equipment, recording
and reporting of test results and the environment · Organization and management
in which the laboratory operates. The laboratory · Quality management system
may have to take certain corrective actions, after · Document control
the final assessment. · Review of contracts
After satisfactory corrective actions are taken by · Examination by referral laboratories
the laboratory (within a period of 3 months), the · External services and supplies
Accreditation Committee will examine the report · Advisory services
and if satisfied recommend accreditation. · Resolution of complaints
· Identification and control of nonconformitis
The time required for the process of accreditation will · Corrective actions
depend upon the preparedness of the laboratory and · Preventive actions
its response to the non - conformances raised during · Continual improvement
the pre-assessment and final assessment. The total · Quality and technical records
duration ranges between 6 and 8 months. · Internal audits
Surveillance and Re-Assessment · Management review
TECHNICAL REQUIREMENTS
Accreditation to a laboratory shall be valid for a period
of three years. NABL shall conduct annual · Personnel
surveillance of the accredited laboratories. The · Accommodation & environmental conditions
laboratories may enhance or reduce the scope of · Laboratory equipment
accreditation during surveillance. · Pre-examination procedures
The laboratories need to apply for renewal of · Examination procedures
accreditation, at least six months before the expiry of · Assuring quality of examination procedures
· Post-examination procedures
validity of accreditation for which a re-assessment
· Reporting of results
shall be conducted.

Reference: A.S .Kanagasabapathy and Pragna Rao LABORATORY ACCREDITATION - PROCEDURAL

GUIDELINES. (2005) Indian Journal of Clinical Biochemistry 186-188.